The following data is part of a premarket notification filed by Quality Electrodynamics, Llc. with the FDA for 8 Ch Knee Speeder.
| Device ID | K152695 |
| 510k Number | K152695 |
| Device Name: | 8 CH Knee SPEEDER |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | QUALITY ELECTRODYNAMICS, LLC. 700 BETA DRIVE STE 100 Mayfield Village, OH 44143 |
| Contact | Kathleen Aras |
| Correspondent | Kathleen Aras QUALITY ELECTRODYNAMICS, LLC. 700 BETA DRIVE STE 100 Mayfield Village, OH 44143 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2015-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814848020652 | K152695 | 000 |